NC TREK NEO™ 1400225-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648232350), received between Jul 18, 2023 and May 19, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY #3 THAT IS 90% STENOSED. DURING ADVANCEMENT OF THE 2.25X12MM NC TREK NEO RX BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS ENCOUNTERED AT THE LESION. ONCE AT THE LESION FOR PREDILATION, THE NC TREK NEO BALLOON RUPTURED DURING THE INITIAL INFLATION AT 10 ATMOSPHERES. THE BDC WAS WITHDRAWN AND A TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25220479 ↗
• MalfunctionDec 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MILDLY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 75% STENOSED. ONCE AT THE LESION FOR POST-DILATION, THE BALLOON OF THE 2.25 X 12 MM NC TREK NEO BALLOON DILATATION CATHETER RUPTURED AT 12 ATMOSPHERES DURING THE INITIAL INFLATION. A NEW TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926225 ↗
• MalfunctionNov 21, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE NC TREK NEO RX 2.25 X 12MM WAS TO BE USED IN THE LEFT ANTERIOR DESCENDING (LAD) LESION. RESISTANCE WAS FELT DURING ADVANCEMENT TO THE TARGET LESION. HOWEVER, THE NC TREK RUPTURED AT 8 ATMOSPHERES DURING THE SECOND INFLATION. THEREFORE, THE NC TREK WAS REMOVED AND ANOTHER NC TREK WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617003 ↗
• MalfunctionNov 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A RESTENOSED HEAVILY CALCIFIED, MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED. THE BALLOON OF A 2.25X12MM NC TREK NEO BALLOON DILATATION CATHETER, RUPTURED AT 10 ATMOSPHERES DURING THE SECOND INFLATION. A NEW NC TREK NEO WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457865 ↗
• MalfunctionAug 29, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY THAT IS 90% STENOSED. THE 2.25X12MM NC TREK NEO BALLOON DILATATION MET RESISTANCE WITH ANATOMY DURING ADVANCEMENT TO THE LESION. ONCE AT THE LESION DURING THE SECOND INFLATION THE BALLOON RUPTURED AT 8 ATMOSPHERES. THE PROCEDURE WAS CONTINUED WITH ANOTHER NC TREK BALLOON. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22925784 ↗
• MalfunctionMar 4, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. THE 2.25X12MM RX NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE NOTED DUE TO INTERACTIONS WITH THE ANATOMY. THE BALLOON RUPTURED DURING THE THIRD INFLATION AT 8 ATMOSPHERES. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21513691 ↗
• MalfunctionJul 3, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE 2.25 X 12MM NC TREK NEO RX WAS TO BE USED IN THE LEFT ANTERIOR DESCENDING (LAD) LESION WITH RESISTANCE DUE TO THE ANATOMY. THE BALLOON RUPTURED AT 12 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THEREFORE, THE BALLOON WAS REMOVED AND NC TREK NEO OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19670918 ↗
• MalfunctionJul 18, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 2.25X12MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE ADVANCED TO TARGET LESION; HOWEVER, FAILED TO ADVANCE DUE TO RESISTANCE WITH THE LESION. THEREFORE, THE BDC WAS REMOVED FROM THE ANATOMY AND RESISTANCE WAS ALSO NOTED DUE TO THE LESION. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17347367 ↗